Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Hemoglobin A1c Test System
510(k) Number K200904
Device Name Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Applicant Contact Louise Musante
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Correspondent Contact Louise Musante
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received04/06/2020
Decision Date 08/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-